Multi-Format Cartridge & Prefilled Syringe (PFS) Filling Machine
The ALWELL Combi Aseptic Filling & Stoppering Line is a highly versatile, multi-format packaging solution engineered for biopharmaceutical companies, CDMOs, and medical aesthetic manufacturers. Designed to process both Dental/Insulin Cartridges (1.5ml to 3.0ml) and Nested RTU Prefilled Syringes (0.5ml to 20ml) on a single compact platform, this line maximizes production flexibility while strictly adhering to cGMP, EU-GMP Annex 1, and FDA 21 CFR Part 11 standards.
1. Multi-Format Versatility & Rapid Changeover Engineering
Eliminate the need for separate dedicated packaging lines. The ALWELL Combi system bridges the gap between different parenteral containers through intelligent modular engineering:
- Dual Stoppering Physics: Integrates both Bottom Plunger Insertion (for glass cartridges used in insulin pens and dental local anesthetics) and Vacuum Plunger Placement (for prefilled syringes containing high-viscosity dermal gels or biologics).
- 30-Minute Tool-Less Changeover: Universal starwheels, quick-release nest adapters, and pre-saved PLC recipes allow operators to switch between cartridges and syringes in under 30 minutes.
- Scratch-Free Container Handling: Servo-driven starwheels and gentle robotic grippers prevent glass-to-glass contact, ensuring zero cosmetic scratches or particle generation in Class A cleanrooms.
2. Supported Products & Dosing Technologies
Whether handling low-viscosity aqueous formulations or shear-sensitive biopharmaceuticals, ALWELL offers custom-tailored pumping systems:
- Insulin, GLP-1 & Metabolic Biologics (Cartridges): Dosed via ultra-precise Ceramic Rotary Piston Pumps ensuring volume accuracy within ≤ ± 1%.
- Hyaluronic Acid & Dermal Fillers (PFS): Utilizes high-vacuum filling and vacuum stoppering (-0.098 MPa) to achieve 100% bubble-free sealing in high-viscosity gels.
- Vaccines & Monoclonal Antibodies (PFS/Cartridges): Compatible with single-use peristaltic pump manifolds to eliminate cleaning validation and prevent shear-induced protein denaturation.
3. Technical Specifications Table
| Specification Parameter | ALWELL Combi Cartridge & PFS Line Standard |
|---|---|
| Container Compatibility | Cartridges: 1.5 ml, 1.8 ml, 3.0 ml | PFS: 0.5 ml, 1 ml long, 2.25 ml, 5 ml, 10 ml (Glass/COP) |
| Production Speed | 1,200 – 3,600 PPH (Higher speeds customizable with multi-head nozzles) |
| Dosing Accuracy | ≤ ± 0.5% (Water-based solutions) | ≤ ± 1.0% (Viscous gels) |
| Stoppering Methods | Mechanical Bottom Insertion (Cartridges) / Active Vacuum Stoppering (PFS) |
| Aluminum Crimping Head | Particle-Free Rotary Crimping System for Cartridge Aluminum Caps |
| Cleanroom Barrier Integration | Class A / ISO 5 Laminar Flow, Open RABS, Closed RABS (cRABS), VHP Isolator Ready |
| Control System & Data Integrity | Siemens S7-1500 PLC, 21 CFR Part 11 Audit Trail, Multi-Tier User Management |
Pharmaceutical cartridge filling
RTU Nested PFS Vacuum Filing Stoppering llachine, this equipment is a vacuum filing and fling machine specialy developed by our company foivanious RTU pre-fling and sealing packaging matenials. itis compatible with RTU packaging materals such as pre-flina svringes, cassette boilesand Vial botles. lt adopts fullservo control, vacuum filing and fling. lt has the advantages of smal area, wide range of adaptabity, high fiing accuracy, no bubbles, and is easy to clean, easy to operate and easy to maintain. The whole machine design fuly conforms to the requirements ofGMP, suitable for allkinds of hyaluronic acid, collagen, vegetable protein,third generation hyaluronic acid (including microspheres), chitosan, sodiumhvaluronate, gel, crosslinked products,haluronic acid,water needle, insulin and other materials fiing, widely used in medical beauty, biopharmaceuti.cal and other fields.
Pharmaceutical cartridge filling
aseptic operation
The machine is equipped with hundreds of laminar flow, with aseptic operation glove box, the whole process of aseptic environment operation.
Servo control
Servo control of the whole machine, vacuum filling and vacuum plug are controlled separately, and the vacuum degree is adjustable.
high-precision
Vacuum gas pipeline is equipped with Burst filter and sanitary diaphragmvalve, and equipped with high-precision vacuum sensor, effectively monitor.
automatic
Can be linked to other equipment of our company to achieve automatic needleremoval, light inspection, Bubble and particle detection automatic rod labeling.
filling finished Products
why choose us
pre-filled syring filling specialist,focusing on the filling line research and development of prefilled syringe.
Frequently Asked Questions (FAQ) for Dual-Use Line Procurement
Q1: How does a single machine handle both prefilled syringes and dental/insulin cartridges?
A: The ALWELL Combi Filler utilizes a modular station architecture. For cartridges, it engages a bottom rubber plunger insertion mechanism and an aluminum cap crimping head. For RTU prefilled syringes, it switches to top vacuum stoppering mode and bypasses crimping. Quick-change starwheels and PLC recipe selection allow seamless transition between formats.
Q2: How do you prevent particulate contamination during cartridge aluminum cap crimping in Class A cleanrooms?
A: We utilize specialized smooth rotary knife-style crimping heads rather than traditional press-style jaws. This gentle rotational sealing process applies precise torque without scraping the aluminum alloy, ensuring zero metal dust or particulate generation in accordance with EU-GMP Annex 1 requirements.
Q3: Is the combi filling machine suitable for CDMOs with frequent product switchovers?
A: Absolutely. CDMOs benefit significantly from this platform because it drastically reduces capital expenditure and cleanroom footprint. Tool-less format changeover takes under 30 minutes, and the system supports single-use disposable fluid paths for zero cross-contamination and minimal cleaning validation between batches.
Q4: Can we integrate a 100% In-Process Control (IPC) checkweighing system into this line?
A: Yes. An optional non-destructive 100% IPC dynamic checkweighing system can be installed along the main indexing starwheel. It weighs every empty syringe/cartridge before filling and re-weighs it after dosing, automatically adjusting pump displacement via real-time feedback loops.
Q5: What FAT, SAT, and validation documentation do you provide for regulatory submission?
A: We supply a comprehensive validation binder including DQ, IQ, OQ, PQ execution templates, 21 CFR Part 11 software compliance certificates, material 3.1 traceabilities, surface roughness reports, and live FAT video testing to support your FDA, EMA, or NMPA line audits.
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